Providing Proven Expertise in:

• Electronic Common Technical Document (eCTD)
• Document Templates and Template Development
• Electronic Document Management Systems (EDMS)
• Desktop and Submission Publishing
• Submission Process Development -
  • Electronic and Paper Submissions
  • Investigational and Marketing Applications
  • Review and Approval
  • Standard Operating Procedures
• System Selection, Implementation, and Management
• Computer System Validation (IQ, OQ , PQ )